Use Instructions
Table Of Contents
- GLOSSARY & ACRONYMS
- PART 1. GENERAL SYSTEM INFORMATION
- 2. INDICATIONS AND CONTRAINDICATIONS FOR USE
- 3. WARNINGS AND PRECAUTIONS
- CAUTION
- 6. BASELINE MEASUREMENT PREPARATION AND DEVICE SETUP
- 8. THE ALIGNMENT TOOL
- PART 3. AT-HOME CPM SYSTEM USE
- PART 4. LIGHTS, SOUNDS, AND TROUBLESHOOTING
- 12. CPM DEVICE LIGHTS AND SOUNDS
- 13. BASE STATION INDICATIONS
- 14. BUTTON PRESSES
- 15. GENERAL TROUBLESHOOTING / FAQS
- 15.1 Physician Q&As
- Q: No data from my patient is appearing on the server, but after getting in touch with the patient, they say that they have been taking measurements consistently with no issue and their device is connected to a plugged- in Base Station.
- Q: No size of the CPM Device fits my patient.
- Q: I initiated a patient mode measurement while trying to put the device into Bluetooth pairing mode and now I can’t pair the CPM Device to the Mobile App.
- Q: How do patients get more adhesives when they run out?
- Q: Can the CPM System be used near other electronic or medical equipment such as telephones, televisions, computers, etc.?
- Q: Is data secure when transmitting from the CPM Device to the Mobile App, the Device to the Base Station, or the Base Station to the Cloud platform?
- 15.2 Patient Q&As
- Q: The CPM Device is not lighting up when plugged into the Base Station to charge.
- Q: Nothing happens when I am trying to start a measurement and/or the button is pressed on the CPM Device.
- Q: The device visually does not stick well to my body or is obviously peeling up.
- Q: I lost the clear protective liners for covering the adhesive.
- Q: I pressed the button accidentally/too early and a measurement started before the device was on my body. How do I get the device to stop beeping?
- Q: The CPM Device continues to beep, indicating there are errors, during a measurement.
- Q: Can I shower with the CPM Device or get it wet?
- Q: Can I travel with the CPM System?
- Q: A piece or part broke off the device, base station, or alignment tool.
- Q: What do I do if I think I am having a medical emergency or decompensation event?
- 15.1 Physician Q&As
- PART 5. CLEANING AND MAINTENANCE
- PART 6. SYSTEM SPECIFICATIONS
- PART 7. SYMBOLS GLOSSARY
54
Version C
Clinician Instructions for Use – Device and Mobile Application
C
IEC 62133-2
Secondary cells and batteries containing alkaline or other non-acid
electrolytes – Safety requirements for portable sealed secondary lithium
cells, and for batteries made from them, for use in portable applications –
Part 2: Lithium systems
BS EN 60601-1-6
Medical Electrical Equipment. General Requirements for Basic
Safety and Essential Performance. Collateral Standard. Usability
BS EN ISO 10993-10
Biological evaluation of medical devices - Part 10: Tests for irritation and
skin sensitization
EN ISO 10993-5
Biological evaluation of medical devices -- Part 5: Tests for in vitro
cytotoxicity
ANSI AAMI EC57
Testing and reporting performance results of cardiac rhythm and ST-
segment measurement algorithms
AAMI TIR69
Risk Management of Radio-Frequency Wireless Coexistence for Medical
Devices and Systems
ISO 27000-1
Information technology — Security techniques — Information security
management systems — Requirements
ISO 14117
Active implantable medical devices — Electromagnetic compatibility —
EMC test protocols for implantable cardiac pacemakers, implantable
cardioverter defibrillators and cardiac resynchronization devices
AAMI/ANSI/IEC 62304
Medical Device Software – Software Life cycle processes
- Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices
EMC guidance and manufacturer’s declarations
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all medical electrical
equipment. This device complies with IEC 60601-1-2 ed 4.0 (2014-02).
All medical electrical equipment must be installed and put into service in accordance with the EMC
information provided in this document.
Portable and mobile RF communications equipment (e.g: cell phones) can affect the behavior of medical
electrical equipment. The use of accessories and cables other than those specified may result in increased
emissions or decreased immunity.
The device should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is
necessary, it should be observed in order to verify normal operation in the configuration in which it will be
used.
The ADI CPM system complies with all applicable and required standards for electromagnetic interference:
It does not normally affect nearby equipment and devices.
It is not normally affected by nearby equipment and devices.
It is not safe to operate the ADI CPM System in the presence of high-frequency surgical equipment or MRI.
However, it is good practice to avoid using the ADI CPM System in extremely close proximity to other
equipment.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions